Allos Therapeutics, Inc. (NASDAQ:ALTH) today announced topline
results from the Company’s randomized Phase 2b investigational
trial of FOLOTYN® (pralatrexate injection) versus erlotinib in
patients with Stage IIIB/IV (advanced) non-small cell lung cancer
(NSCLC) who had received one or two prior systemic treatments
including at least one prior platinum-based regimen. The objective
of the trial was to estimate the efficacy of FOLOTYN compared to
that of erlotinib as assessed by overall survival. The results
demonstrated clinical activity of FOLOTYN in this patient
population.
The primary endpoint of the trial was overall survival. Patients
receiving FOLOTYN had a 16 percent reduction in the risk of death
compared to erlotinib in the overall patient population (n=201;
hazard ratio (HR)=0.84) and a 13 percent reduction in the risk of
death in the primary efficacy analysis population (n=166;
HR=0.87).
Analyses were also performed in predefined patient cohorts,
including light vs. heavy smokers, current vs. former smokers,
squamous vs. non-squamous histology, and patients who received
prior pemetrexed vs. those who had not. The largest reductions in
risk of death for FOLOTYN were observed in patients with
non-squamous cell carcinoma (n=107; HR=0.65) and light smokers
(n=37; HR=0.63), with the results demonstrating a 35 percent and 37
percent reduction in the risk of death, respectively. Positive
trends in overall survival were observed in favor of FOLOTYN in all
other patient cohorts except patients with squamous cell carcinoma
and patients who received prior pemetrexed.
The safety profile of FOLOTYN was consistent with that observed
and reported in previous FOLOTYN solid tumor studies. The most
common Grade 3-4 adverse event observed in patients treated with
FOLOTYN was mucositis (23 percent). Other Grade 3-4 adverse events
occurring in more than 5 percent (but less than 10 percent) of
patients were fatigue, dyspnea, neutropenia, thrombocytopenia and
anemia in patients treated with FOLOTYN and rash, dyspnea, anemia
and fatigue in patients treated with erlotinib.
“We are pleased that the results of this trial demonstrated
clinical activity of FOLOTYN in a randomized study compared to
erlotinib, an approved active agent in non-small cell lung cancer,”
said Charles Morris, MB ChB, MRCP, chief medical officer at Allos
Therapeutics. “We will continue to review these important data with
our expert advisors to further evaluate the clinical potential of
FOLOTYN in this patient population. We also plan to submit the
complete study results for presentation at an upcoming medical
meeting.”
“This study generated important data regarding the safety and
efficacy profile for FOLOTYN in advanced non-small cell lung
cancer, an area of high unmet medical need,” said Paul L. Berns,
chief executive officer at Allos Therapeutics. “We believe these
data warrant further analysis to determine the future development
strategy based on our assessment of the potential clinical,
regulatory and commercial opportunities for FOLOTYN in this
indication.”
About the Study Design
This randomized, open-label, international, multi-center Phase
2b study comparing FOLOTYN versus erlotinib, marketed as TARCEVA®,
enrolled 201 current or former smokers with Stage IIIB/IV
(advanced) NSCLC who had received one or two previous treatments
including at least one prior platinum-based chemotherapy regimen.
The objective of the trial was to estimate the efficacy of FOLOTYN
compared to that of erlotinib as assessed by overall survival. The
primary endpoint of the trial was overall survival. Secondary
endpoints included progression-free survival and response rate,
both compared to erlotinib, and the safety and tolerability of
FOLOTYN. The study was not designed to show a statistically
significant difference between the two treatment arms. No
definition of statistical significance was included in the analysis
plan.
The trial – which enrolled patients across 43 locations
worldwide (15 U.S. sites and 28 ex-U.S. sites) – was initiated by
Allos in January 2008 and completed enrollment in July 2009. The
first 35 patients enrolled in the study were randomly assigned
one-to-one to receive FOLOTYN (intravenous push on days 1 and 15 of
a 28-day cycle; initial dose of 230 mg/m2) or erlotinib (oral, 150
mg daily in a 28-day cycle). Subsequently, following a protocol
amendment, 166 patients were randomly assigned one-to-one to
receive either FOLOTYN at 190 mg/m2 or erlotinib at 150 mg/day and
then further stratified by light and heavy smokers. All patients
received concurrent vitamin therapy of B12 and folic acid.
According to the statistical analysis plan, the full analysis set
included all 201 patients who were randomized in the study and the
primary efficacy analysis included the 166 patients enrolled
subsequent to the protocol amendment.
About Lung Cancer
More people die each year from lung cancer than any other type
of cancer – including breast, prostate, and colorectal cancers
combined. In 2010, it is estimated that there will be more than
200,000 new cases of lung cancer diagnosed in the United States and
over 150,000 deaths. There are primarily two types of lung cancer:
NSCLC and small cell lung cancer (SCLC). NSCLC accounts for the
majority of lung cancers (about 87 percent) and develops slowly –
often causing few or no symptoms until very late stages. The most
common subtypes of NSCLC are squamous cell carcinoma,
adenocarcinoma, and large-cell undifferentiated carcinoma; squamous
cell carcinomas account for 25-30 percent of all lung cancers while
adenocarcinoma and large-cell undifferentiated carcinoma account
for 40 percent and 10-15 percent of lung cancers, respectively. The
majority of people are diagnosed with advanced stage disease and
only one to five percent of people with advanced stage (IIIB/IV)
NSCLC survive to five years. The most widely used therapies to date
remain surgery, chemotherapy, and radiation therapy.
Conference Call Information
Today, the Company issued a press release announcing its second
quarter 2010 financial results. The Company will host a conference
call to review its financial results and the topline results from
the Phase 2b trial of trial of FOLOTYN versus erlotinib in patients
with advanced non-small cell lung cancer on Wednesday, July 28,
2010 at 8:30 a.m. ET. Participants can access the call at
1-866-225-8754 (U.S. and Canada) or +480-629-9690 (international).
To access the live audio webcast or the subsequent archived
recording, visit the “Investors - Presentations and Events” section
of Allos’ website at www.allos.com. Webcast and telephone replays
of the conference call will be available approximately two hours
after the completion of the call. Callers can access the replay by
dialing 800-406-7325 (domestic) or 303-590-3030 (international).
The passcode is 4329512#. The webcast will be recorded and
available for replay on Allos’ website until August 11, 2010.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq:ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. Allos is currently focused on
the development and commercialization of FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma.
Allos is also developing FOLOTYN in other hematologic malignancies
and solid tumors. Allos retains exclusive worldwide rights to
FOLOTYN for all indications. Allos is headquartered in Westminster,
CO. For additional information, please visit www.allos.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.Mucositis may occur.
If ≥ Grade 2 mucositis is observed, omit or modify dose.Patients
should be instructed to take folic acid and receive vitamin B12 to
potentially reduce treatment-related hematological toxicity and
mucositis.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN, and pregnant women
should be informed of the potential harm to the fetus.Use caution
and monitor patients when administering FOLOTYN to patients with
moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are ≥ Grade 3,
omit or modify dose.
Dermatologic reactions may occur. Patients with dermatologic
reactions should be monitored closely.
Adverse Reactions:
The most common adverse reactions observed were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events were pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea and thrombocytopenia.
Use in Specific Patient Population:
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result
in delayed renal clearance.
For additional important safety information, please see the full
prescribing information for FOLOTYN at www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements regarding the potential safety and
efficacy of FOLOTYN for the treatment of patients with advanced
non-small cell lung cancer, the potential development of FOLOTYN
for the treatment of advanced non-small cell lung cancer; and other
statements that are other than statements of historical facts. In
some cases, you can identify forward-looking statements by
terminology such as “may,” “will,” “should,” “expects,” “intends,”
“plans,” anticipates,” “believes,” “estimates,” “predicts,”
“projects,” “potential,” “continue,” and other similar terminology
or the negative of these terms, but their absence does not mean
that a particular statement is not forward-looking. Such
forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual
results to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties include,
among others: that data from preclinical studies and clinical
trials may not necessarily be indicative of future clinical trial
results; that the safety and/or efficacy profile for FOLOTYN may
not support further clinical development in advanced non-small cell
lung cancer; and the risk that the Company may lack the financial
resources and access to capital to fund future clinical trials for
FOLOTYN. Additional information concerning these and other factors
that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q for the quarter ended June 30, 2010, and in the Company's
other periodic reports and filings with the Securities and Exchange
Commission. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this press
release. All forward-looking statements are based on information
currently available to the Company on the date hereof, and the
Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.TARCEVA is a registered trademark of OSI
Pharmaceuticals, Inc.
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